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OsseoFit Stemless Shoulder System for Shoulder Injuries and Arthritis

This study is looking at the OsseoFit Stemless Shoulder System (Anatomic) to see how safe and effective it is for people with shoulder problems like injuries, pain, fractures, or arthritis. This system uses special implants, either the OsseoFit Stemless Inlay (which sits inside the bone) or the OsseoFit Stemless Onlay (which sits on top of the bone). Researchers want to understand how well these implants work, if there are any problems during or after surgery, and how they affect your shoulder function and quality of life. The main goal is to see how much your shoulder pain and function improve after two years. About 136 people are expected to join this study.

Study design
This is an observational study, meaning researchers will watch and collect information about your experience with the OsseoFit Stemless Shoulder System. It plans to enroll about 136 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for at least two years to assess your shoulder function and pain, and for up to 10 years to track the implant's survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07421245

OsseoFit Stemless Shoulder System (Anatomic)

Not Yet Recruiting
Not specifiedAges 20+Observational
Zimmer Biomet
~136 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:OsseoFit Stemless InlayOsseoFit Stemless Onlay

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
the American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Measured over 2 years

Conditions

Shoulder Injuries
Shoulder Pain
Shoulder Fractures
Shoulder Arthritis
Shoulder Disease

Explore related trials

Osteoarthritis

Where it's being run

2 sites across 2 states
New Jersey1
New York1

Study leadership

  • Jim Nevelos · STUDY_DIRECTOR · Zimmer Biomet

Who to contact

Octavia Gladden
[email protected]
(704) 493-0178
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient must be 20 years of age or older.
The patient must be anatomically and structurally suited, as evident by scapula and proximal humerus closure, to receive the implants.
Patient planned to receive OsseoFit™ anchor with uncemented fixation.
Patient planned to receive a Modular Alliance Glenoid with bone cement. The porous posts must be coated with Porous Plasma Spray (PPS) and may be inserted without bone cement.
Patient planned to receive shoulder arthroplasty due to osteoarthritis.
Patient must be able and willing to complete the protocol required follow-up schedule.
Patient must be able and willing to sign the IRB approved consent.

Exclusion

Patient is unwilling or unable to give consent or to comply with the follow-up program.
Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.
Patient is known to be pregnant or breastfeeding.
Patient is a vulnerable participant (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non-compliant).
Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.
Patient has any neuromuscular disease compromising the affected limb.
Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site. This may include:
Local/systemic infection
Sepsis
Osteomyelitis
Patient presents with Osteomalacia.
Patient presents with a humeral bone fracture.
Patient presents with malunion or non-union of the tuberosities of the proximal humerus.
Patient has had a previous operative shoulder prosthesis (stem or stemless).
Patient has irreparable cuff tear.
Patient presents with inadequate humeral bone, which in the opinion of the Investigator, may lead to poor implant fixation. This may include but is not limited to:
Osteoporosis
Extensive Avascular Necrosis
Rheumatoid Arthritis
Metaphyseal bony defects (including large cysts)

What this trial measures

  • the American Shoulder and Elbow Surgeons (ASES) Shoulder Score2 years

    The primary endpoint is the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Improvement from baseline to 2 years will be evaluated using the overall mean change, with effectiveness demonstrated if the mean improvement exceeds the MCID of 10.8 points. The primary endpoint analysis will use the ITT population with all available data and no imputation. Hypotheses: H0: μCFB ≤ 10.8; H1: μCFB \> 10.8, where μCFB is the mean ASES change (2 years minus baseline). The MCID of 10.8 was established using the 0.5 SD distribution method based on psychometric evaluation of ASES scores from 3,667 shoulder arthroplasty patients with ≥2-year follow-up.